IgG Next Generation has been approved in Germany, Austria and the United Kingdom under the trade name Yimmugo®. In other European countries and in the USA, the approval process has been initiated. Clinical development was successfully completed in two pivotal phase III trials: Study No. 991 for the treatment of patients with primary (congenital) immunodeficiencies (PID) and Study No. 992 for the treatment of patients with immune thrombocytopenia (ITP). The development for further indications is planned
Clinical trials
The following clinical trials have been conducted and completed:
IgG Next Generation (Study 991) / Yimmugo: Primary Immune Deficiency (PID)
An open label, prospective, multicenter phase III study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT595 as replacement therapy in patients with primary immunodeficiency disease (PID)
https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-003652-52/DE
IgG Next Generation (Study 992) / Yimmugo: Idiopathic Thrombocytopenic Purpura (ITP)
An open label, prospective, randomized, multicenter phase III study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP)
https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-003653-17/ES